Does Part 11 apply in this case

We have work order forms which are hard copies that are signed and filed. Copies are then used to issues paper work and information such as lot #, expiration date, etc are written in by hand and verified before issuance.

Now management wants to use a database system to add the information so they avoid mistakes from hand writing and other transcription errors.

This new way is just a word document of the work order and the signatures at the bottom scanned in. My concern is from a regulatory point of view. Do we need to be concerned with Part 11 and what other concerns should I worry about such as security of the electronic version and preservation of the integrity of the original document?

Please all comments, suggestion, and thoughts are welcome.


Is the hardcopy printed from this database and then used?

Is the offical or primary record the hardcopy or the stored electronic version?

The hardcopy is not printed from the database. It was made in word printed then signed and filed. The offical version is the hardcopy not the electronic.

They will be using an electronic version of the hardcopy to print out information that used to be hand written.

Hmm, I’m a little bit confused!

If the offical copy is the hard copy what is the point of the electronic system?

from my point of view PART 11 DOES NOT APPLY HERE, as the hard copy is also generated from a word file then initiation for production must be from a stable production plan based on the inventory that is available. this work order must have been raised on a production request form. however If this is the procedure followed then the best practice is to have the cronological lot numbering which can be typed on to the work order along with the manufacturing date. THIS SYSTEM IS APPLICABLE ONLY IF THE ORGANIZATION PROCEDURE IS TO have the date of manufacturing is the date of raising the work order.
which procedure do you follow. there are two other methods of alloting the manufacturing dates.

The point of the electronic system is to take the human factor out of writing in information on the paper work. They have to write in such information as Lot #/Exp Date, Work Order Number, Item Number and so on. They want to remove the human factor and use a computer input to save time and hopefully errors

I was going through this interesting discussion and was wondering if the ms-access based change control tracking application which auto generates change control number, allow the user to enter the change request information, print the change control forms and track the status of change control needs to be part 11 compliant, though electronic records are not used as official copy but only the printout generated (change control forms) from this application is used as official copy.

In other words we are using this application as any other word document, to enter information and to print it ,the only different is the application will stores the information, automatically assign change control number for each change request, informs and allow only the respective user role to complete and print his section of the change request.

Please comment…


I would take a conservative approach here, and suggest that you deem Electronic Records requirements (but not electronic signature requirements) as applicable, and validate the system accordingly.It will also help a future move to a completely electronic environment, less painful, and less costly.

All records ( those falling in the scope of predicate rule) if generated by printing from electronic storage and maintained as hard copies but relying on original electronically stored data for other regulatory work fall into the scope of 21 CFR Part 11.
All paper records printed out of e-records shall have automated date and time stamping… not hand filled one. That software facility has to be validated and shall be under control.

Hi Seal

Part 11 is purely about regulatory controlled predicate data. The data a regulator would expect to able to access and review during an inspection or on request. If a regulator asks to review data, then you must retrieve it from your hard copy files or archives, and it must look and appear the same age as the data conception. If you go to a PC and print it out, then your system must be Part 11 compliant.

Your initial use of manually completed hard copy sounds fine. However in the adding of data to this hard copy, are you in any way affecting the original data, or could any of the additional data be considered as regulatory controlled data?

Thereby hangs the problem. If your original hard copy is changed so that a software package becomes the master reference for any of the predicate data (i.e. dates, titles, reference numbers, serial number, operator identities, etc.) Then your software package must be Part 11 compliant.

During a regulatory inspection would your manually drafted hard copy contain all the information a regulator would want to view?

If not and any data was originated, manipulated or stored, electronically, then the system used must be part 11 compliant.

I would advise you to discuss it with the person in your company who would face the regulator during an inspection, he/she is the one person in the company that certainly does not want to cut corners.

Incidentally before I close, let me say, a scanned signature is completely and utterly worthless, and should never be used seriously. Far better to print in full the persons name and give a contact reference (URL, file, phone number, etc), where the signatory’s identity and authorities can be confirmed.

Alex Kennedy

I was going through this interesting thread and I ve got a querry in relation to this.

If the change control form is generated through a database system, the form would require approvals by different review team in a sequence. Though there is a final hard copy made available, would this approvals fall under Part 11 ES regulations, as the CCR is a GxP record?